Sandostatine LAR in Dumping syndrome - Dumping Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003250-98-BE

Enrollment

Registered

2005-10-04

Start date

2005-08-26

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dumping Syndrome is a condition characterized by weakness, dizziness, flushing and warmth, nausea and palpitation immediately or shortly after eating and produced by abnormally rapid emptying of the stomach in persons who have had part of the stomach removed or in hypersensitive or neurotic individuals

Interventions

Trade Name: Sandostatine 0,1 mg/ml Product Name: Octreotide Product Code: SMS995 Pharmaceutical Form: Solution for injection INN or Proposed INN: Octreotide Trade Name: Sandostatine LAR 20 mg Product

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) > 10, and a. a positive OGTT, in terms of a glycemia 3%, or an increase of pulse rate by 10 bpm Or b. documented spontaneous hypoglycemia (at least 1) 2. Age > 18 years 3. Diet of 6 meals a day with low concentration of mono- and disaccharides during 1 month before inclusion without sufficient improvement (= evaluation by physician and patient)=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients who haven’t been treated with Sandostatine during the last 6 months. 2. Cholecystolithiasis 3. Diabetes Mellitus 4. Coeliakie and Giardia 5. Severe oesophagitis 6. Gastric and duodenum ulcer 7. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (d) female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). 8. Hypersensitivity to octreotide or one of the compounds of the drug

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of Sandostatine LAR on a specific Patient Assessment Scale and on a specific dumping score in patients tolerating well Sandostatine subcutaneously.;Secondary Objective: Secondary objectives : 1. To assess the effect of Sandostatine s.c. on an oral glucose tolerance test (OGTT). 2. To assess the effect of Sandostatine LAR on OGTT. 3. To assess the effect of Sandostatine LAR on a quality of life (QOL) questionnaire. 4. To assess the tolerability of Sandostatine LAR;Primary end point(s): Evaluation of the effect of Sandostatin® LAR in patients with dumping syndrome who tolerates well Sandostatine® s.c. via a patient assessment scale and dumping score table	—

Measure

Time frame

Main Objective: To assess the effect of Sandostatine LAR on a specific Patient Assessment Scale and on a specific dumping score in patients tolerating well Sandostatine subcutaneously.;Secondary Objective: Secondary objectives : 1. To assess the effect of Sandostatine s.c. on an oral glucose tolerance test (OGTT). 2. To assess the effect of Sandostatine LAR on OGTT. 3. To assess the effect of Sandostatine LAR on a quality of life (QOL) questionnaire. 4. To assess the tolerability of Sandostatine LAR;Primary end point(s): Evaluation of the effect of Sandostatin® LAR in patients with dumping syndrome who tolerates well Sandostatine® s.c. via a patient assessment scale and dumping score table

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026